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MK-8189 for Schizophrenia

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The main inclusion
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 17 days
Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it is tolerated by people with schizophrenia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants discontinuing study treatment due to an AE
Number of participants experiencing an Adverse Event (AE)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338
18%
Weight increased
13%
Sedation
11%
Headache
9%
Dizziness
9%
Akathisia
9%
Nausea
7%
Fatigue
7%
Dyspepsia
7%
Lethargy
7%
Agitation
4%
Schizophrenia
4%
Somnolence
2%
Decreased appetite
2%
Vomiting
2%
Anxiety
2%
Alcohol poisoning
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risperidone
MK-8189
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-8189 Panel CExperimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Days 1-2 and 80 mg on Day 3 based on safety and tolerability.
Group II: MK-8189 Panel A-1Experimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Day 1 and 80 mg on Day 2.
Group III: MK-8189 Panel AExperimental Treatment1 Intervention
Participants will receive MK-8189 starting at 48 mg on Day 1 and 60 mg on Day 2.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive MK-8189-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,907 Previous Clinical Trials
5,065,965 Total Patients Enrolled
23 Trials studying Schizophrenia
2,633 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,789 Previous Clinical Trials
8,067,199 Total Patients Enrolled
28 Trials studying Schizophrenia
4,285 Patients Enrolled for Schizophrenia
~19 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
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